The present invention relates to ostomy devices of the type including a waste collection pouch adapted to be adhesively affixed to the skin surrounding the stoma and more particularly to such a device which provides increased strength, improved breathability and better odor protection.
Certain surgical procedures known as colostomy, ileostomy and urostomy result in an opening in the abdominal wall, called a stoma, which permits waste discharge from the interior of a body cavity. Since the patient has no control over the waste discharge, it is often necessary for the patients who have undergone these surgical procedures to utilize an ostomy device to protect the stoma and collect the waste material as it is discharged.
Over the years, ostomy devices of a variety of different types and constructions have been utlized. Various materials and adhesives have been developed to increase the utility and wareability of same.
The basic device includes a collection receptacle or pouch connected to an adhesive coated faceplate which serves to mount the pouch to the body. The pouch includes first and second thin film walls which are sealed by heat welding or the like along the periphery. The pouch has an inlet opening designed to be aligned with the stoma and an outlet for emptying material from the pouch. In single piece devices, the pouch is permanently affixed to the adhesive coated faceplate. In two piece devices, the pouch is detachably mounted to the faceplate by coupling rings or the like, permitting the pouch to be replaced without removal of the faceplace each time.
For the ostomy device to function properly, it is important that it make a fluid-tight connection with the peristomal skin to prevent any liquid, solid, semi-solid or gaseous waste from escaping. It is also important to provide a weight bearing connection to support the weight of the device.
The proper functioning of the device also requires that the components of the device which are joined together during manufacture remain completely attached to each other over the entire period of use. One of the problems which is encountered is that it is difficult to reliably join the components together because of the different materials involved. Thus, during use of the device, components may begin to become detached. However, the materials are selected because of the specific properties required such as skin compatability, which is of primary importance.
This is particularly true of the hydrocolloid disk portion of the faceplate which forms a seal with the skin surrounding the stoma. The hydrocolloid material is commonly carried on a polyethylene film. This film acts as an odor barrier. It also provides a base for the disk to be secured to the pouch.
The disk carries an adhesive collar which is the other portion of the faceplate. The collar consists of a non-woven polyester material upon which the adhesive layer is situated. Although this polyester material is weldable, it cannot be welded to the pouch material because too high a temperature is required. Thus, the collar must be carried on the disk, which can be welded to the pouch.
The hydrocolloid disk and in particular the polyethylene film is welded to the pouch along a thin ring-like section which surrounds the relatively large pouch inlet opening. The collar has a central opening which must be large enough to accomodate the section of the disk which is welded to the pouch. The perpherial portion of the disk, outside of the welded section, is rather thin and is overlapped by the collar by a only small amount. The adhesive holds the collar on the disk only along this relatively thin overlapping area.
It has been found that in use, the hydrocolloid material may tend to separate from the polyethylene film. In addition, because of the large central opening required for collar, resulting in a relatively thin area for the adhesive bond with the disk film, the collar may tend to separate from the disk.
Another problem relates to odor. It has been found if fecal material in the pouch is absorbed into the hydrocolloid material, the hydrocolloid material in time will begin to give off an odor. The conventional polyethylene film does not completely protect against wicking of liquid stool material from inside the pouch.
These problems are overcome in the present invention through the use of different materials for the film of the hydrocolloid disk and for the collar, as well as a change in the shape of the collar. These material changes permit the collar to be welded directly to the pouch in the one piece appliance and be secured directly to the coupling ring in the two piece embodiment. The change in collar shape greatly increases the area in which the collar may be attached to the disk. This increases the overall strength of the device and reduces the possibility for the components becoming detached during use. These changes also result in improved skin breathability and serve to improve the effectiveness of the odor barrier.